RISK EVALUATION AND MITIGATION STRATEGY (REMS) Single Shared System for Mycophenolate

Transcription

1 Initial REMS Approval: 09/25/2012 Most Recent Modification: 09/2013 RISK EVALUATION AND MITIGATION STRATEGY (REMS) Single Shared System for Mycophenolate

2 I. GOALS The goals of the Mycophenolate REMS are: 1. To prevent unplanned pregnancy in patients using mycophenolate and to minimize fetal exposure to mycophenolate by informing prescribers and females of reproductive potential about: the increased risk of first trimester pregnancy loss and congenital malformation associated with exposure to mycophenolate during pregnancy; and the importance of pregnancy prevention and planning 2. To minimize the risks associated with fetal exposure to mycophenolate by collecting information on pregnancy outcomes through the Mycophenolate Pregnancy Registry 3. To inform patients about the serious risks associated with mycophenolate. II. REMS ELEMENTS A. Medication Guide A Medication Guide will be dispensed with each mycophenolate prescription in accordance with 21 CFR The Medication Guides for mycophenolate-containing products are part of the Mycophenolate REMS and will be available on the Mycophenolate REMS website ( B. Elements to Assure Safe Use 1. Healthcare providers who prescribe mycophenolate will receive training. a) Mycophenolate sponsors will ensure that training will be provided to healthcare providers who prescribe mycophenolate-containing products. To become trained, each prescriber will be provided with the Mycophenolate Program Brochure for Healthcare Providers. The brochure includes the following information: i. The risk of first trimester pregnancy loss and congenital malformations associated with mycophenolate ii. iii. Importance of educating females of reproductive potential about the increased risk of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy Importance of prescribers providing or facilitating patient education about pregnancy prevention and planning, including acceptable methods of contraception during mycophenolate treatment

3 iv. Importance of only prescribing mycophenolate to a pregnant patient if the benefits of initiating or continuing treatment outweigh the risk of fetal harm v. Importance of reporting to the Pregnancy Registry any pregnancies that occur during mycophenolate treatment or within 6 weeks following discontinuation of treatment vi. vii. Importance of encouraging pregnant patients to participate in the Pregnancy Registry Importance of obtaining a signed Patient-Prescriber Acknowledgement Form from each female of reproductive potential. The Patient-Prescriber Acknowledgement Form is part of the Mycophenolate REMS and is appended b) Mycophenolate sponsors will ensure that prescribers can successfully report that they have taken the training via the Mycophenolate REMS website, mail, fax, or by scanning and ing the Prescriber Training Confirmation Form. The Prescriber Training Confirmation Form is part of the Mycophenolate REMS and is appended. c) Mycophenolate sponsors will maintain a list of all healthcare providers (HCPs) who have completed the Mycophenolate REMS Training. d) Mycophenolate sponsors will redistribute the training materials every two years or following substantive changes that affect the Mycophenolate REMS. Substantive changes are defined as 1) significant changes to the operation of the Mycophenolate REMS; 2) changes to the Prescribing Information and Medication Guide that affect the risk-benefit profile of mycophenolate. e) Mycophenolate sponsors will provide educational materials and a DHCP Letter for Centers to centers (e.g., transplant centers) that choose to administer training to their prescribers through their own centralized process. Mycophenolate sponsors will ensure that a designee of the Center can successfully report the healthcare providers who have participated in the training via the Mycophenolate REMS website, mail, fax, or by scanning and e- mailing the Center Training Confirmation Form. The Center Training Confirmation Form is part of the Mycophenolate REMS and is appended. The DHCP Letter for Centers is part of the Mycophenolate REMS and is appended. f) Mycophenolate sponsors will submit for publication a Journal Information Piece in the following journals: Transplantation American Journal of Transplantation Neurology Arthritis & Rheumatism Journal of the American Academy of Dermatology Journal of the American Society of Nephrology

4 Obstetrics and Gynecology Pediatrics American Family Physician This piece is designed to convey the risks of mycophenolate products, the importance of completing the training, and details on where and how educational materials can be accessed. It will appear monthly for the first 6 months after FDA approval of the REMS and every other month in the subsequent 6 months. The Journal Information Piece is part of the Mycophenolate REMS and is appended. g) Mycophenolate sponsors will ensure that no later than 8 weeks after approval of the REMS, a Dear Healthcare Professional (DHCP) Introductory Letter will be sent to all HCPs who prescribed mycophenolate in the 24 months preceding REMS approval, accompanied by program materials (Prescriber Kit and Patient Kit). Mycophenolate sponsors will ensure that no later than 8 weeks after approval of the REMS, a DHCP Introductory Letter will be sent to all HCPs who: are on the following American Medical Association subspecialty lists: allergy and immunology, immunology, cardiology, dermatology [including surgery, and dermatopathology], gastroenterology, neurology [including surgery and neuropathology], OB/GYN [including maternal fetal medicine], general surgery, thoracic surgery, transplantation surgery, hepatology, nephrology, and rheumatology and all corresponding pediatric subspecialties, and; have not prescribed mycophenolate in the 24 months preceding REMS approval. The DHCP Introductory Letter is designed to convey and reinforce the increased risks of first trimester pregnancy loss and congenital malformation associated with mycophenolate exposure during pregnancy and the importance of prescribers completing the training and will include important safety information about products that contain mycophenolate. The DHCP Introductory Letter will also provide details on where and how educational materials can be ordered. The letter will be available on the Mycophenolate REMS website for 1 year from the date of distribution. The DHCP Introductory Letter is part of the Mycophenolate REMS and is appended. h) Mycophenolate sponsors will maintain a call center to support prescribers interfacing with the Mycophenolate REMS. i) Mycophenolate sponsors will monitor distribution and prescription data monthly to identify new prescribers who should be trained.

5 j) The following materials are part of the Mycophenolate REMS and are appended: Mycophenolate REMS Brochure for Healthcare Providers Patient-Prescriber Acknowledgement Form Prescriber Training Confirmation Form Center Training Confirmation Form DHCP Letter for Centers Journal Information Piece DHCP Introductory Letter Obstetrician/Gynecologist Referral Template Letters for Contraception Counseling Obstetrician/Gynecologist Referral Template Letters for Preconception Counseling Mycophenolate REMS Overview for Patients and Your Birth Control Options Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients Mycophenolate REMS Website These materials will also be available on the Mycophenolate REMS website or by calling the Mycophenolate REMS call center at Mycophenolate sponsors will maintain a centralized pregnancy registry for females who become pregnant and consent to participate. The primary objectives of the Pregnancy Registry are to: Document maternal and fetal outcomes of each exposed pregnancy to further characterize the risk of mycophenolate fetal exposure. Determine mycophenolate exposure status for each reported pregnancy Understand the circumstances that led to the fetal exposure (root cause analysis) Identify factors that affect the risk of adverse outcomes such as dose, timing of exposure, or maternal characteristics III. Timetable for Submission of Assessments Mycophenolate NDA sponsors will submit REMS assessments to FDA every 6 months for the first year from the date of initial approval of the Mycophenolate REMS and annually thereafter. To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by

6 each submission will conclude no earlier than 60 days before the submission date for that assessment. The assessment will be submitted so that it is received by the FDA on or before the due date.

7 BROCHURE FOR HEALTHCARE PROVIDER

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9 Table of Contents Introducing Mycophenolate REMS 3 Mycophenolate- Related First Trimester Pregnancy Loss and Congenital Malformations.5 Your Role in Mycophenolate REMS.. 6 Reporting a Pregnancy..10 Frequently Asked Questions About Mycophenolate REMS and the Mycophenolate Pregnancy Registry 11 Mycophenolate REMS Resources 14 2

10 Introducing Mycophenolate REMS Mycophenolate REMS (Risk Evaluation and Mitigation Strategy) has been mandated by the FDA (Food and Drug Administration) due to postmarketing reports showing that exposure to mycophenolate during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. While available data are limited, structural malformations occur in approximately 20% of live-born infants exposed in utero to mycophenolate and first trimester pregnancy loss rates are higher.* The FDA determined that a REMS is necessary to ensure that the benefits of mycophenolate outweigh the risks of first trimester pregnancy loss and congenital malformations associated with mycophenolate use during pregnancy. Mycophenolate is available by prescription as: CellCept (mycophenolate mofetil) Myfortic (mycophenolic acid) Generic formulations of mycophenolate mofetil Generic formulations of mycophenolic acid The goals of the Mycophenolate REMS are: 1. To prevent unplanned pregnancy in patients using mycophenolate and to minimize fetal exposure to mycophenolate by informing prescribers and females of reproductive potential about: The increased risks of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy; and The importance of pregnancy prevention and planning 2. To minimize the risks associated with fetal exposure to mycophenolate by collecting information on pregnancy outcomes through the Mycophenolate Pregnancy Registry 3. To inform patients about the serious risks associated with mycophenolate *Sifontis NM, et al. Pregnancy outcomes in solid organ transplant recipients with exposure to mycophenolate mofetil or sirolimus. Transplantation. 2006;82: Prescribing Information for mycophenolate. For complete safety information, please see full Prescribing Information, including Boxed WARNING and Medication Guide, which can be found at 3

11 Introducing Mycophenolate REMS (cont d) All prescribers of mycophenolate and females of reproductive potential, whether or not they plan to get pregnant, should be aware of the risks associated with mycophenolate. Females of reproductive potential include girls who have entered puberty and all women who have a uterus and have not passed through menopause. This brochure, the Mycophenolate REMS Brochure for Healthcare Providers, has been designed to help you understand the components of Mycophenolate REMS. Included are details on what you can do to help ensure the successful implementation of Mycophenolate REMS so that patients understand the risks associated with exposure to mycophenolate during pregnancy. Menopause is the permanent end of menstruation and fertility. Menopause should be clinically confirmed by a patient s healthcare practitioner. Some commonly used diagnostic criteria include: months of spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical therapy); or 2. Postsurgical from a bilateral oophorectomy 4

12 Mycophenolate-Related First Trimester Pregnancy Loss and Congenital Malformations Mycophenolate can cause fetal harm when administered to a pregnant female. Exposure to mycophenolate during pregnancy is associated with an increased risk of: First trimester pregnancy loss Congenital malformations (especially external ear and abnormalities such as a cleft lip and palate) Anomalies in babies of the distal limbs, heart, esophagus and kidney In December 2006, the National Transplantation Pregnancy Registry (NTPR) published data from prospective cases where 24 female transplant patients reported 33 mycophenolate-exposed pregnancies.* Of these pregnancies, there were: 15 spontaneous abortions (45%) 18 live-born infants Four of the 18 live-born infants had structural malformations (22%) The reported malformations were similar to findings in animal reproductive toxicology studies. For comparison, background rate for congenital anomalies in the United States is about 3% and the NTPR data show a rate of 4% to 5% among babies born to organ-transplant patients using other immunosuppressive drugs. Because these postmarketing data are reported voluntarily, it is not always possible to reliably estimate the frequency of particular outcomes. When initiating or continuing treatment with mycophenolate, you should educate females of reproductive potential on the risks associated with exposure to mycophenolate during pregnancy. They need to make informed decisions about treatment. Of the 77 females exposed to systemic mycophenolate during pregnancy that were reported in postmarketing data (collected between 1995 and 2007): 25 had spontaneous abortions 14 had a malformed fetus or infant Six of the 14 malformed offspring had ear abnormalities *Sifontis NM, et al. Pregnancy outcomes in solid organ transplant recipients with exposure to mycophenolate mofetil or sirolimus. Transplantation. 2006;82: Prescribing Information for mycophenolate. 5

13 Your Role in Mycophenolate REMS You need to complete the following steps to help ensure the successful implementation of Mycophenolate REMS with females of reproductive potential: 1. Enroll in Mycophenolate REMS 2. Check Pregnancy Status 3. Educate Females of Reproductive Potential 4. Obtain a Signed Patient-Prescriber Acknowledgment Form 5. Report Any Mycophenolate-Exposed Pregnancies 1. Enroll in Mycophenolate REMS You should become familiar with the risks of embryofetal toxicity associated with mycophenolate and the requirements of Mycophenolate REMS. As a prescriber of mycophenolate, you should enroll in Mycophenolate REMS by completing a Prescriber Training Confirmation Form to document that you understand, and will comply with Mycophenolate REMS. You can submit a Prescriber Training Confirmation Form to Mycophenolate REMS by one of several ways: Visit and complete the online form Complete a hard copy and submit it via fax to Complete a hard copy and mail it to: Mycophenolate REMS 200 Pinecrest Plaza Morgantown, WV Call This brochure is not a comprehensive description of the risks associated with the use of mycophenolate. 6

14 Your Role in Mycophenolate REMS (cont d) 2. Check Pregnancy Status You must determine if females of reproductive potential are pregnant: One pregnancy test with a sensitivity of at least 25 miu/ml should be done immediately before starting mycophenolate Another pregnancy test with the same sensitivity should be done 8 to 10 days later Repeat pregnancy tests should be performed at routine followup visits Results of all pregnancy tests should be discussed with the patient In the event of a positive pregnancy test, discuss the risks and benefits of treatment with the patient. The patient should be apprised of the potential hazard to the fetus. In certain situations, you and the patient may decide the maternal benefits outweigh the risks to the fetus. 3. Educate Females of Reproductive Potential Educate females about the risks of mycophenolate exposure during pregnancy. Before initiating or continuing treatment, you must educate females of reproductive potential by discussing with them the increased risks of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy. The information you share in this discussion will be reinforced by the Mycophenolate REMS Overview & Your Birth Control Options booklet. Provide females of reproductive potential with a Mycophenolate REMS Overview & Your Birth Control Options booklet. You should ensure that they understand their role in Mycophenolate REMS. Provide pregnancy planning education Advise patients using mycophenolate to let you know if they are considering pregnancy. For a patient considering pregnancy, determine whether there are appropriate treatment options with less potential for embryofetal toxicity. In addition, it is important to optimize the patient s underlying medical condition(s) and nutritional status prior to conception. Refer patients for pre-conception counseling and high risk obstetrical care as needed and coordinate care among the patient s established providers. Provide contraception counseling Unless patients choose not to have sexual intercourse with a man at any time (abstinence), you must instruct them to always use acceptable contraception: During entire treatment with mycophenolate For 6 weeks after they stop taking mycophenolate 7

15 Your Role in Mycophenolate REMS (cont d) The following table lists the forms of contraception that are acceptable for use during treatment with mycophenolate. Guide your patients to choose from the following birth control options: Acceptable Contraception Methods for Females of Reproductive Potential* Option 1 Methods to Use Alone Intrauterine devices (IUDs) Tubal sterilization Patient s partner had a vasectomy OR Option 2 Choose One Hormone Method AND One Barrier Method OR Hormone Methods choose 1 Estrogen and Progesterone Oral contraceptive pill Transdermal patch Vaginal ring Progesterone-only Injection Implant AND Barrier Methods choose 1 Diaphragm with spermicide Cervical cap with spermicide Contraceptive sponge Male condom Female condom Option 3 Choose One Barrier Method from each column (must choose two methods) Barrier Methods choose 1 Diaphragm with spermicide Cervical cap with spermicide Contraceptive sponge AND Barrier Methods choose 1 Male condom Female condom *Females of reproductive potential include girls who have entered puberty and all women who have a uterus and have not passed through menopause. 8

16 Your Role in Mycophenolate REMS (cont d) EMERGENCY CONTRACEPTION Patients should also be counseled on the availability of emergency contraception in the event they have intercourse without acceptable contraception or their contraceptive methods fail. Patients 17 years and older can purchase emergency contraception over the counter. Patients can call the Emergency Contraception Hotline * at NOT-2-LATE ( ) to get information on how to obtain emergency contraception. * Mycophenolate REMS is neither affiliated with nor an endorser of this organization. The information provided by Mycophenolate REMS or this organization is meant for informational purposes only, and is not intended to replace medical advice to your patients. 4. Obtain a signed Patient-Prescriber Acknowledgment Form After you have educated females of reproductive potential on the risks associated with exposure to mycophenolate during pregnancy and have counseled them on contraception and pregnancy planning, have them acknowledge this by signing a Patient-Prescriber Acknowledgment Form. By signing this form, patients agree that they will comply with Mycophenolate REMS requirements. For patients who are minors, a legal guardian should sign in addition to the patient. You too, as the prescriber, should sign the form and give a copy to the patient. 5. Report any pregnancies to the Mycophenolate Pregnancy Registry The Mycophenolate Pregnancy Registry has been established to evaluate mycophenolate-exposed pregnancies and their outcomes. This will provide an opportunity to learn more about mycophenolate exposure in utero. Instruct patients to tell you if they get pregnant during treatment with mycophenolate or within 6 weeks following discontinuation of treatment. If you learn that a patient is pregnant: Report the pregnancy to the Mycophenolate Pregnancy Registry By phone: Online: or By mail: Mycophenolate Pregnancy Registry 201 Broadway, Suite 5 Cambridge, MA Retain the original copy for your records. 9

17 Reporting a Pregnancy Patients should be informed that you will report any pregnancies of which you become aware to the Mycophenolate Pregnancy Registry. Provision of patient contact and medical information to the Mycophenolate Pregnancy Registry is covered by an HIPAA waiver. The Mycophenolate Pregnancy Registry program administrator will report personally identifiable pregnancy data to the appropriate drug manufacturer for purposes of reporting to regulatory agencies as required by law. Aggregated de-identified data may be shared among participating sponsors of Mycophenolate REMS and/or submitted for publication in peer-reviewed scientific journals. Encourage the patient to participate in the Mycophenolate Pregnancy Registry Provide the patient with Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients 10

18 Frequently Asked Questions About Mycophenolate REMS and the Mycophenolate Pregnancy Registry Who is Mycophenolate REMS for? Mycophenolate REMS is designed to help inform prescribers, nurses, pharmacists, and females of reproductive potential of the risks associated with exposure to mycophenolate during pregnancy. Who can participate in the Mycophenolate Pregnancy Registry? A female patient is considered eligible if she meets either of the following criteria: A patient who is or was pregnant and was exposed to at least 1 dose of mycophenolate during pregnancy A patient who got pregnant within 6 weeks following discontinuation of treatment Patients who meet either of these criteria, regardless of indication, can participate. Patients whose pregnancy does not meet these criteria may not participate in the Mycophenolate Pregnancy Registry. Why is the Mycophenolate Pregnancy Registry important? Exposure to mycophenolate during pregnancy is associated with: Increased risks of pregnancy loss during the first trimester Higher risk of congenital malformations Ear abnormalities such as microtia Facial deformities, including cleft lip and palate Anomalies of the distal limbs, heart, esophagus, and kidney The Mycophenolate Pregnancy Registry will collect data to characterize the risks associated with exposure to mycophenolate during pregnancy or within 6 weeks following discontinuation of treatment, regardless of indication. There is no limit to the number or type of physicians and/or patients who may contribute data to the Mycophenolate Pregnancy Registry. All reports of potential maternal and fetal exposure to mycophenolate will be considered for the Mycophenolate Pregnancy Registry. The success of the Mycophenolate Pregnancy Registry depends on the participation of both patients and healthcare providers. Healthcare providers should identify patients who are currently pregnant or who may have been exposed to mycophenolate while pregnant, inform them of the Mycophenolate Pregnancy Registry, and encourage them to participate in the Mycophenolate Pregnancy Registry. Healthcare providers should report any pregnancy that may involve exposure to mycophenolate, whether or not the patient chooses to participate. Patients should be informed that you will report any pregnancies of which you become aware to the Mycophenolate Pregnancy Registry. 11

19 Frequently Asked Questions About Mycophenolate REMS and the Mycophenolate Pregnancy Registry (cont d) What is my role in the Mycophenolate Pregnancy Registry? Instruct patients to tell you if they get pregnant during treatment with mycophenolate or within 6 weeks following discontinuation of treatment. If you learn that a patient is pregnant Report the pregnancy to the Mycophenolate Pregnancy Registry Encourage the patient to participate in the Mycophenolate Pregnancy Registry When you report an eligible pregnancy to the Mycophenolate Pregnancy Registry, you should provide your contact information. Also provide the Mycophenolate Pregnancy Registry with information about the pregnancy and the patient s contact information so that she can be called for follow-up for this safety study. Provision of patient contact and medical information to the Mycophenolate Pregnancy Registry is covered by an HIPAA waiver. When patients participate in the Mycophenolate Pregnancy Registry, they agree to provide information about their pregnancy, including information about prenatal drug exposure of any duration, maternal demography and history, and maternal and fetal outcomes of pregnancies exposed to mycophenolate. Patients are encouraged to participate in the Mycophenolate Pregnancy Registry as soon as their pregnancy is known, preferably in the first trimester. After I report my patient s pregnancy, what will her participation involve? The patient will be asked in telephone interviews to answer questions regarding her health and her baby s health. These interviews will take place during each trimester of pregnancy; near the expected time of delivery or at pregnancy outcome; and when the infant reaches 2 months, 6 months, and 1 year of age. Since the Mycophenolate Pregnancy Registry relies on being able to contact the patient, it is important for you to advise her to keep the Mycophenolate Pregnancy Registry informed of any changes to her contact information throughout her participation. After I enroll my patient, what is my role? You will be asked to provide pregnancy and outcomes data on a paper-based case report form (CRF) and submit it via mail or fax, or enter the data into an electronic data capture (EDC) system. You must keep the Mycophenolate Pregnancy Registry informed of any changes to your contact information throughout your participation. 12

20 Frequently Asked Questions About Mycophenolate REMS and the Mycophenolate Pregnancy Registry (cont d) How will data collected by the Mycophenolate Pregnancy Registry be analyzed and reported? The Mycophenolate Pregnancy Registry program administrator will report personally identifiable pregnancy data to the appropriate drug manufacturer for purposes of reporting to regulatory agencies as required by law. Aggregated de-identified data may be shared among participating sponsors of Mycophenolate REMS and/or submitted for publication in peer-reviewed scientific journals. How can I obtain more information? Visit Visit Call Do I still report pregnancies to the National Transplantation Pregnancy Registry (NTPR)? All pregnancies occurring during treatment with mycophenolate or within 6 weeks following discontinuation of treatment should be reported to the Mycophenolate Pregnancy Registry, regardless of indication, for inclusion and follow-up. In addition to reporting exposed pregnancies to the Mycophenolate Pregnancy Registry, you may also report pregnancies to the NTPR. 13

21 Mycophenolate REMS Resources Several resources have been developed to help ensure that you and your patients understand the risks associated with exposure to mycophenolate during pregnancy and to help you comply with the requirements of Mycophenolate REMS. These resources, some of which have been described previously, are available either in the Mycophenolate REMS Overview & Your Birth Control Options or online. They include: Mycophenolate REMS Web Site: The Web site provides information about Mycophenolate REMS, including the option to order or download resource materials. Enrollment in Mycophenolate REMS can also be completed on this site Mycophenolate REMS Brochure for Healthcare Providers (this brochure) Prescriber Training Confirmation Form Prescribers enroll in Mycophenolate REMS by completing this form Center Training Confirmation Form Centers enroll in Mycophenolate REMS by completing this form prescribers of mycophenolate to help establish a working relationship with an OB/GYN for patient counseling. There are 2 letter templates one for contraception counseling and one for pregnancy planning education that can be customized for your practice and patient before sending to an OB/GYN Medication Guide There is a separate Medication Guide for each mycophenolate formulation Mycophenolate REMS Overview & Your Birth Control Options This booklet helps patients understand Mycophenolate REMS and gives patients an overview of acceptable forms of contraception. Included in the booklet are Patient-Prescriber Acknowledgment Form HCPs and females of reproductive potential sign this to acknowledge that they have been informed about the risks and will comply with Mycophenolate REMS Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients This document answers some common questions about the Mycophenolate Pregnancy Registry in patient-friendly language Obstetrician/Gynecologist Referral Template Letters These customizable letters available online at can be used by 14

22 Mycophenolate REMS Resources (cont d) Mycophenolate Pregnancy Registry The Mycophenolate Pregnancy Registry evaluates mycophenolate-exposed pregnancies and their outcomes. You can contact the Mycophenolate Pregnancy Registry by calling or visiting For more information about Mycophenolate REMS and for all resource materials Visit Call Additional Resources FOR MORE INFORMATION ABOUT CONTRACEPTION* Association of Reproductive Health Professionals: Planned Parenthood: FOR MORE INFORMATION ABOUT BIRTH DEFECTS* Centers for Disease Control and Prevention: *Mycophenolate REMS is neither affiliated with nor an endorser of these organizations. The information provided by Mycophenolate REMS or these organizations is meant for informational purposes only, and is not intended to replace your medical advice to your patients. 15